The American Society for Microbiology (ASM) is writing in support of the amendment on Antibiotic Access and Innovation which we understand you are offering during floor consideration of the Food and Drug Administration Revitalization Act (S 1082). We believe this amendment is a positive step in addressing a number of important issues that will encourage the development of new antibiotics and improve the treatment of patients with infectious diseases.

The ASM, the single largest life science society with over 42,000 members, is concerned about the growing problem of antimicrobial resistance and public health. Human morbidity and mortality rates tied to antimicrobial resistant pathogens are on the rise in the United States, a public health problem in both healthcare settings and in the greater community. Updated infection control guidelines released in October 2006 from the Centers for Disease Control and Prevention (CDC) state that “the prevention and control of multidrug-resistant organisms in healthcare settings is a national priority that requires that all healthcare facilities and agencies assume responsibility.” Each year nearly 2 million patients in the United States develop infections in healthcare settings, causing more than 90,000 deaths and more than $4.5 billion in excess healthcare costs, making healthcare-associated infections (HAIs) one of the nation’s ten leading causes of death. More than 70 percent of the pathogens causing HAI infections are resistant to at least one of the drugs traditionally used for their treatment.Among the most troubling causes of HAIs are methicillin-resistant Staphylococcus aureus (MRSA), vancomycin-resistant enterococci (VRE), and Clostridium difficile, which together cause at least 350,000 infections and 12,000 deaths annually. Even more alarming has been the sudden increase in the numbers of community-associated MRSA and C. difficile infections witnessed in the United States during the past five years.

Infectious pathogens of global significance also are developing antimicrobial resistance, challenging the ongoing campaigns to eradicate killers like tuberculosis, malaria, and HIV/AIDS. Tuberculosis—which kills one person every 15 seconds worldwide—seems especially threatening according to the CDC report last year of an extensively drug-resistant form of the Mycobacterium tuberculosis (XDR-TB). Virtually untreatable with currently available anti-tuberculosis drugs, XDR-TB succeeded the prior emergence of multidrug-resistant (MDR-TB) infections. MDR-TB has been documented in nearly 90 countries and regions worldwide (including the United States), causing 400,000-450,000 new cases of drug-resistant infection each year. Health officials estimate that one in every ten new tuberculosis infections is caused by a drug-resistant form of M. tuberculosis.

The ASM commends your efforts to include provisions in the FDA Revitalization Act which will help protect patient safety and public health against antimicrobial resistance. The ASM would be pleased to work with Congress to consider additional policy and legislative actions which could help address the critical issue of antimicrobial resistance.